Document Controller

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Document Controller

Contract: 23 Month (Temp) Contract

Location:Tullagreen, Carrigtwohill

The Document Controller will be primarily responsible for the control, review, release and obsolescence of documentation for Stryker site(s), including procedures, drawings and specifications. Will also be responsible for maintaining archiving/storage of all quality records in accordance with the applicable regulatory requirements and standards.

Will work within the Quality Systems team, under general supervision, with responsibility to ensure an effective and efficient management and release of documentation, this includes, but is not limited to the following duties:

What you will do:

• Responsible for all activities related to document routing, distribution and release to assure that the latest effective copies are available as required.
• Ensure prompt archiving and storage of all Stryker documentation.
• Timely retrieval of documents and information, as needed to complete investigations and/or reports.
• Subject Matter Expert for document management procedures, update and revise procedures to improve practices and systems by reflecting the current best practices.
• Subject Matter Expert (super user) for the Product Life-cycle Management system.
• Will provide coaching, training, clinics, support and service to functions in use of and navigation of the PLM system and execution of documentation & change processes.
• Contribute to and drive improvement initiatives within the Quality Systems team, participate in multi-functional teams to achieve collaborative results.
• Effective interface & communication with functional disciplines to ensure efficient and constructive interdepartmental interactions for Documentation aspects.
• Provide training to cross functional groups on PLM and regulatory requirements related to Documentation control.
• Periodic/requested participation in product development team
• Support & comply with GMP/QSR, ISO 13485 & CE-mark requirements.
• Input to & maintain quality KPIs for trending/management reviews.
• Assist in issue investigations, provides input to correction & resolution, rework, problem solving, and process improvements.
• Maintain an organized, clean, safe & health-conscious work environment.
• Assist with company regulatory audit activities, as deemed necessary.

What you will need:

• Third Level Qualification (Diploma in Business Studies or Administration, or equivalent 2 year certification /preferred)
• Relevant experience in a similar administrative type role in a Regulated Industry, advantageous.
• High level of PC skills required, must be highly proficient with Microsoft.
• Have an understanding of archiving systems and methodology and electronic document managing systems.
• Have an understanding of the following standards ISO 13485 and ISO 9000 and CFR Part 820 Quality System Regulations
• Must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines with acute attention to detail
• Is a self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• Be capable of working as part of a multi-disciplined team.

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.